Latest news with #sebetralstat
Medscape
28-07-2025
- Health
- Medscape
EMA Backs First Oral Treatment for Hereditary Angioedema
At its July 2025 meeting, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending marketing authorization for sebetralstat (Ekterly, KalVista Pharmaceuticals) for symptomatic treatment of acute attacks of hereditary angioedema in adults and adolescents aged 12 years or older. Hereditary angioedema is a rare, chronic, and potentially life-threatening genetic condition caused by deficiency or dysfunction of C1 esterase inhibitor, leading to excessive bradykinin and unpredictable swelling episodes in the face, abdomen, limbs, and airways. Sebetralstat is a selective oral plasma kallikrein inhibitor designed for administration at the earliest sign of an angioedema attack. It blocks the overactivation of the kallikrein-kinin system, preventing the formation of bradykinin, a key mediator of swelling in the condition. If approved by the European Commission, the drug will be the first oral on-demand treatment for hereditary angioedema in the European Union. The CHMP opinion was based on efficacy and safety data from a phase 3 KONFIDENT trial, which randomized 136 patients with hereditary angioedema. Findings showed that sebetralstat led to significantly faster symptom relief and reduction in attack severity and attack resolution than placebo. It was also well-tolerated with a safety profile similar to placebo. Ekterly will be available in 300-mg film-coated tablets. The most common side effect reported is headache. One of the key advantages of the drug is its oral route of administration, offering patients a more convenient alternative to injectable therapies. This may significantly reduce the time between an angioedema attack onset and treatment administration. Ekterly was granted orphan medicine status during its development due to its targeted use in a rare, life-threatening condition. The EMA noted that the drug would have been unlikely to be developed without such incentives and is now reviewing the available data to determine whether the orphan designation should be maintained.
Yahoo
10-07-2025
- Business
- Yahoo
KalVista Pharmaceuticals Provides Operational Update and Fiscal Year 2025 Financial Results
– Received FDA approval of EKTERLY® (sebetralstat)—the first and only oral on-demand treatment for hereditary angioedema; U.S. launch underway – – Six additional global regulatory submissions under review – – Entered licensing agreements for sebetralstat commercialization in Japan and Canada – – $220.6M in cash, providing runway into 2027 – CAMBRIDGE, Mass. & SALISBURY, England, July 10, 2025--(BUSINESS WIRE)--KalVista Pharmaceuticals, Inc. (Nasdaq: KALV), today provided an operational update and released financial results for the fiscal year ended April 30, 2025. "The FDA approval of EKTERLY represents a major milestone—not only as the first commercial product for KalVista, but more importantly, as the first and only oral on-demand therapy for people living with HAE," said Ben Palleiko, CEO of KalVista Pharmaceuticals. "EKTERLY delivers a long-awaited treatment that is safe, effective, and easy to administer. Our commercial team is actively engaging in the field, leveraging their expertise to educate and activate patients and physicians to enable timely access, drive awareness, and support informed treatment decisions around this important new therapy. With commercial partners now in place in Canada and Japan, and six global regulatory submissions under review, we believe EKTERLY is poised to become the foundational therapy for HAE management worldwide." Recent Business Highlights EKTERLY® (sebetralstat) On July 7, 2025, KalVista announced FDA approval of EKTERLY (sebetralstat), a novel plasma kallikrein inhibitor, for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. KalVista further strengthened the robust body of clinical evidence supporting the efficacy and safety of EKTERLY (sebetralstat) for the treatment of HAE. The Company presented new data at the European Academy of Allergy and Clinical Immunology Congress 2025 (EAACI), the 14th C1-inhibitor Deficiency & Angioedema (C1-INH) Workshop in Budapest, Hungary, and the Eastern Allergy Conference (EAC) in Palm Beach, Florida. Key highlights from these medical congresses are outlined below: EAACI: Data showed the efficacy of EKTERLY (sebetralstat) for the on-demand treatment of HAE attacks among patients receiving long-term prophylaxis (LTP). Real world data highlighted significant challenges with LTP adherence, and ongoing reliance on on-demand medications. In KONFIDENT-S, EKTERLY (sebetralstat) delivered rapid, consistent relief for attacks, regardless of LTP mechanism of action with a median time to beginning of symptom relief of 1.3 hours. C1-INH: Analysis from nearly 1,600 attacks in KONFIDENT-S showed a median time to end of attack progression of 19.8 minutes. These results aligned closely with KONFIDENT, reinforcing the rapid effect of EKTERLY (sebetralstat) after absorption. Interim data from KONFIDENT-S highlighted the role of EKTERLY (sebetralstat) in treating mucosal attacks with a median time to beginning of symptom relief of 1.3 hours for both abdominal and laryngeal attacks. EAC: In KONFIDENT-S, EKTERLY (sebetralstat) was used to treat 76 attacks that had progressed to severe or very severe after a median of 2.16 hours from attack onset, demonstrating its utility in more advanced stages of HAE attacks. The median time to beginning of symptom relief for these attacks was 1.36 hours, with reduction in attack severity and substantial reduction of symptom burden in a median of 1.77 hours and 9.15 hours, respectively. Organizational In April, KalVista entered into an exclusive agreement with Kaken Pharmaceutical, Co., Ltd. to commercialize sebetralstat in Japan. Under the terms of the deal, in June 2025 KalVista received an upfront payment of $11 million, and an additional $11 million will be paid upon achieving a regulatory milestone anticipated in early 2026. This agreement also includes potential commercial milestone payments of up to $2 million and royalties based on the Japan National Health Insurance (NHI) price, with royalties expected to be in the mid-twenties as a percentage of sales. In June, KalVista granted Pendopharm, a division of Pharmascience Inc., the exclusive rights to manage the regulatory approval process and commercialization of sebetralstat in Canada. Financial Results for Fiscal Year Ended April 30, 2025: Research and development expenses were $71.7 million and $86.2 million for the fiscal years ended April 30, 2025, and 2024, respectively. The decrease in R&D was primarily attributable to reduced clinical trial expenses, preclinical activities and recognizing expense associated with EKTERLY (sebetralstat) pre-commercial awareness within General & Administrative. General and administrative expenses were $116.3 million and $54.3 million for the fiscal years ended April 30, 2025, and 2024, respectively. The increase in G&A expenses was primarily due to pre-commercial planning expenses related to EKTERLY (sebetralstat). Cash, cash equivalents and marketable securities were $220.6 million on April 30, 2025, compared to $210.4 million on April 30, 2024. About KalVista Pharmaceuticals, Inc. KalVista Pharmaceuticals, Inc., is a global biopharmaceutical company dedicated to developing and delivering life-changing oral therapies for individuals affected by rare diseases with significant unmet needs. In the U.S., KalVista markets EKTERLY®, the first and only oral on-demand treatment for hereditary angioedema (HAE). The Company has multiple regulatory applications under review in key global markets. For more information about KalVista, please visit and follow us on LinkedIn, X, Facebook and Instagram. Forward-Looking Statements This press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, information relating to our business and business plans, the success of our efforts to commercialize EKTERLY® (sebetralstat), our ability to successfully obtain foreign regulatory approvals for sebetralstat, our expectations about the safety and efficacy of sebetralstat and our other product candidates, the timing of clinical trials and their results, our ability to commence clinical studies or complete ongoing clinical studies, including our KONFIDENT-S and KONFIDENT-KID trials, and the ability of EKTERLY to treat HAE , and the future progress and potential success of our oral Factor XIIa program. Further information on potential risk factors that could affect our business and financial results are detailed in our filings with the Securities and Exchange Commission, including in our annual report on Form 10-K for the year ended April 30, 2025, our quarterly reports on Form 10-Q, and our other reports that we may make from time to time with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. KALVISTA PHARMACEUTICALS, INC. Consolidated Balance Sheets April 30, 2025 and 2024 (in thousands except share and per share amounts) (Unaudited) 2025 2024 Cash, cash equivalents & Marketable securities $ 220,617 $ 210,401 Other current assets 21,073 15,289 Total current assets 241,690 225,690 Other assets 9,080 9,714 Total assets $ 250,770 $ 235,404 Current liabilities $ 45,167 $ 22,807 Long-term liabilities 110,212 6,015 Total Liabilities 155,379 28,822 Stockholders' equity 95,391 206,582 Total liabilities and stockholders' equity $ 250,770 $ 235,404 KALVISTA PHARMACEUTICALS, INC. Consolidated Statements of Operations and Comprehensive Loss Years Ended April 30, 2025 and 2024 (in thousands, except share and per share amounts) (Unaudited) 2025 2024 Research and development $ 71,709 $ 86,167 General and administrative 116,286 54,278 Total operating expenses 187,995 140,445 Operating loss (187,995 ) (140,445 ) Other income: Interest income 6,435 3,896 Interest (expense) (5,785 ) — Foreign currency exchange gain (loss) 2,481 138 Other income (expenses), net 4,812 9,767 Total other income 7,943 13,801 Loss before income taxes (180,052 ) (126,644 ) Income tax (benefit) expense 3,392 — Net loss $ (183,444 ) $ (126,644 ) Net loss per share, basic and diluted $ (3.69 ) $ (3.44 ) Weighted average common shares outstanding, basic and diluted 49,652,878 36,786,575 View source version on Contacts Investors: Ryan BakerHead, Investor Relations(617) Media: Molly CameronDirector, Corporate Communications(857) Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Cision Canada
08-07-2025
- Business
- Cision Canada
DRI Healthcare Comments on FDA Approval and our Increased Investment in KalVista Pharmaceuticals' Ekterly® (sebetralstat)
– Ekterly is the first and only oral on-demand therapy for treating attacks associated with hereditary angioedema – – DRI Healthcare is entitled to a tiered royalty on worldwide net sales of Ekterly – – KalVista has elected to receive additional funding increasing our total investment to $127 million – TORONTO, July 8, 2025 /CNW/ - DRI Healthcare Trust (TSX: (TSX: DHT.U) ("DRI Healthcare") today announced KalVista Pharmaceuticals ("KalVista") has disclosed it has received approval from the U.S. Food and Drug Administration ("FDA") for Ekterly (sebetralstat). Ekterly is approved for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. HAE is a rare genetic disorder characterized by recurring episodes of severe swelling in various parts of the body, including the face, extremities, gastrointestinal tract, and airways. "We are very pleased that the FDA has approved Ekterly as the first and only oral on-demand therapy for treating HAE attacks," said Ali Hedayat, Chief Executive Officer of DRI Healthcare. "The addition of the long-dated Ekterly cash flows demonstrates the value that a pre-approval transaction can bring to our portfolio." "We congratulate our partners at KalVista, who worked diligently to develop Ekterly to help transform the lives of patients who suffer from HAE," added Navin Jacob, Executive Vice President & Chief Investment Officer. KalVista has notified DRI Healthcare that it has elected to receive the optional payment of $22 million as part of the November 2024 royalty transaction. As a result of receiving this one-time payment, the royalty rate on the first sales tranche steps up and the sales-based milestone amount increases. The transaction now entitles DRI Healthcare to a tiered royalty of 6.00% on net sales up to and including $500 million, 1.10% on net sales above $500 million and up to and including $750 million, and 0.25% on net sales above $750 million. KalVista is entitled to a potential one-time sales-based milestone payment of $57 million if annual worldwide net sales of sebetralstat meet or exceed $550 million in any calendar year before January 1, 2031. About DRI Healthcare DRI Healthcare is a pioneer in global pharmaceutical royalty monetization. Since our founding in 1989, we have deployed more than $3.0 billion, acquiring more than 75 royalties on 45-plus drugs, including Ekterly, Eylea, Keytruda, Orserdu, Remicade, Spinraza, Stelara, Vonjo and Zytiga. DRI Healthcare's units are listed and trade on the Toronto Stock Exchange in Canadian dollars under the symbol " and in U.S. dollars under the symbol "DHT.U". To learn more, visit or follow us on LinkedIn.
National Post
26-06-2025
- Business
- National Post
KalVista Pharmaceuticals Enters into Licensing Agreement with Pendopharm to Commercialize Sebetralstat for HAE in Canada
Article content -Sebetralstat has potential to become first oral on-demand treatment for HAE in Canada- Article content -Pendopharm brings proven track record in commercializing innovative therapies across multiple therapeutic areas with capabilities to launch sebetralstat in Canadian market- Article content Article content CAMBRIDGE, Mass. & SALISBURY, England — KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that its wholly-owned subsidiary, KalVista Pharmaceuticals, Ltd., has granted Pendopharm, a division of Pharmascience Inc., the exclusive rights to manage the regulatory approval process and commercialization of sebetralstat in Canada. Sebetralstat is an investigational, oral on-demand treatment for hereditary angioedema (HAE). Article content 'We look forward to collaborating with Pendopharm, whose deep knowledge of the Canadian market and proven track record make them a strong partner as we work to bring sebetralstat to people living with HAE,' said Ben Palleiko, CEO of KalVista. 'This partnership supports our broader goal of making sebetralstat available globally, as the first and only oral on-demand treatment that has the potential to transform HAE care.' Article content Financial terms of the agreement are not being disclosed. Article content About Sebetralstat Article content Sebetralstat is an investigational, novel oral plasma kallikrein inhibitor for the treatment of hereditary angioedema (HAE). We have filed multiple regulatory applications seeking approval of sebetralstat as the first oral, on-demand treatment for HAE in individuals aged 12 and older and are investigating its use in children aged 2 to 11. If approved, sebetralstat has the potential to become the foundational therapy for HAE management worldwide. Article content About Hereditary Angioedema Article content Hereditary angioedema (HAE) is a rare genetic disease resulting in deficiency or dysfunction in the C1 esterase inhibitor (C1INH) protein and subsequent uncontrolled activation of the kallikrein-kinin system. People living with HAE experience painful and debilitating attacks of tissue swelling in various locations of the body that can be life-threatening depending on the area affected. All currently approved on-demand treatment options require either intravenous or subcutaneous administration. Article content About KalVista Pharmaceuticals, Inc. Article content KalVista Pharmaceuticals, Inc., is a global biopharmaceutical company dedicated to developing and delivering life-changing oral therapies for individuals affected by rare diseases with significant unmet needs. Our lead investigational product is sebetralstat, a novel, oral, on-demand treatment for hereditary angioedema (HAE). Sebetralstat is under regulatory review by the U.S. FDA. In addition, we have completed Marketing Authorization Applications for sebetralstat to the European Medicines Agency and multiple other global regulatory authorities. Article content About Pendopharm Article content Pendopharm, a division of Pharmascience Inc., is a Canadian specialty pharmaceutical company that partners with various companies to bring treatments in areas such as rare diseases, gastroenterology, sports medicine, neurology, and cardiology to the Canadian market. For more information about Pendopharm, please visit Article content About Pharmascience Inc. Article content Headquartered in Montreal, Pharmascience Inc. is one of Canada's largest pharmaceutical manufacturers, supplying high-quality medicines to over 50 countries. Its global reach and agile development model ensure timely responses to patient needs worldwide. Article content Forward-Looking Statements Article content This press release contains 'forward-looking' statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: 'anticipate,' 'intend,' 'plan,' 'goal,' 'seek,' 'believe,' 'project,' 'estimate,' 'expect,' 'strategy,' 'future,' 'likely,' 'may,' 'should,' 'will,' and similar references to future periods. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, timings or outcomes of communications with the FDA, our expectations about safety and efficacy of our product candidates and timing of clinical trials and its results, our ability to commence clinical studies or complete ongoing clinical studies, including our KONFIDENT-S and KONFIDENT-KID trials, and to obtain regulatory approvals for sebetralstat and other candidates in development, the success of any efforts to commercialize sebetralstat, the ability of sebetralstat and other candidates in development to treat HAE or other diseases, and the future progress and potential success of our oral Factor XIIa program. Further information on potential risk factors that could affect our business and financial results are detailed in our filings with the Securities and Exchange Commission, including in our annual report on Form 10-K for the year ended April 30, 2024, our quarterly reports on Form 10-Q, and our other reports that we make from time to time with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments, or otherwise. Article content Article content Article content Article content Article content Contacts Article content
Cision Canada
13-06-2025
- Business
- Cision Canada
DRI Healthcare Trust Comments on FDA Delay for KalVista Pharmaceuticals' Sebetralstat PDUFA Goal Date Due to FDA Resourcing Constraints
- FDA decision anticipated within four weeks - TORONTO, June 13, 2025 /CNW/ - DRI Healthcare Trust (TSX: (TSX: DHT.U) (the "Trust") today announced KalVista Pharmaceuticals ("KalVista") has disclosed that it has received notice from the U.S. Food and Drug Administration ("FDA") that the FDA will not meet the June 17, 2025 PDUFA goal date for the New Drug Application (NDA) for sebetralstat, due to a heavy workload and agency resourcing issues. KalVista commented that the FDA has not requested additional data or studies and has communicated to KalVista that it anticipates delivering a decision within approximately four weeks. KalVista issued its own press release with the announcement earlier today (link). About DRI Healthcare Trust The Trust is managed by DRI Capital Inc., a pioneer in global pharmaceutical royalty monetization. Since its initial public offering in 2021, the Trust has deployed more than $1.0 billion, acquiring more than 25 royalties on 20-plus drugs, including Eylea, Orserdu, Omidria, Spinraza, Stelara, Vonjo, Zejula and Zytiga. The Trust's units are listed and trade on the Toronto Stock Exchange in Canadian dollars under the symbol " and in U.S. dollars under the symbol "DHT.U". To learn more, visit or follow us on LinkedIn. SOURCE DRI Healthcare Trust
